Required by the

Generic Drug User Fee Amendments

As amended

Food and Drug Administration

Department of Health and Human Services

April 2017

Printable Version of the FY2016 GDUFA Financial Report

• Printable Version of the FY2016 GDUFA Financial Report

Table of Contents

• Executive Summary-FY2016 GDUFA Financial Report
• Background-FY2016 GDUFA Financial Report
• Legal Conditions-FY2016 GDUFA Financial Report
• User Fee Collections-FY2016 GDUFA Financial Report
• User Fee Obligations-FY2016 GDUFA Financial Report
• Carryover Balances-FY2016 GDUFA Financial Report
• Collections Realized-FY2016 GDUFA Financial Report
• Reserves and Balances Available for Allocation-FY2016 GDUFA Financial Report
• Total GDUFA Program Costs-FY2016 GDUFA Financial Report
• Full-Time Equivalent-FY2016 GDUFA Financial Reports

Appendices

• Appendix A-Conditions for Assessment and Uses of Fees
• Appendix B-Fees, Rates, and Fee Paying Submission Trends
• Appendix C-Included and Excluded Costs for the GDUFA Program
• Appendix D-Development of Costs for the GDUFA Program